Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion
Zimmer, Inc. is recalling NexGen Femoral Components because the packaging bags adhere to the device surfaces. The recall covers 11,694 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a packaging adhesion issue without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
Zimmer, Inc. is recalling the NexGen Femoral Component (CR-FLEX GSF POR FEM) due to a packaging defect. The low density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices.
The recall involves 11,694 units with part numbers ranging from 5752 to 5762. These devices are distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and Mexico.
The source text does not specify any reported injuries, illnesses, or deaths associated with this recall. The issue is identified as a physical adhesion between the packaging material and the device surface.
The recalled product
- Product
- NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR…
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 11,694
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number Range: 5752 and 5762.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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